CLARENCE, N.Y.--(BUSINESS WIRE)--22nd Century Group, Inc. (NYSE MKT: XXII),
a plant biotechnology company that is a leader in tobacco harm
reduction, announced today that on December 31, 2015, the Company’s
wholly owned subsidiary, Goodrich Tobacco Company, submitted a Modified
Risk Tobacco Product (MRTP) application to the U.S. Food and Drug
Administration (FDA) seeking a reduced exposure order so that 22nd
Century’s “BRAND A” Very Low Nicotine (VLN) cigarettes may be introduced
into commerce in the United States. The application to the FDA requests
that BRAND A packaging and marketing be allowed to disclose to consumers
that the Company’s proprietary Very Low Nicotine cigarettes reduce
smokers’ exposure to nicotine.

The World’s Lowest Nicotine Tobacco Cigarettes

BRAND A cigarettes contain less than 0.6 mg nicotine per cigarette and
less than 0.05 mg nicotine yield per cigarette. In each case, this
represents a reduction of at least 95% less nicotine relative to “Big
Tobacco” cigarette brands, including Marlboro®, Camel®, Newport®, and
American Spirit®. With more than 200 patents relating to the genes in
the tobacco plant responsible for nicotine production, 22nd Century is
the only company in the world capable of producing virtually
nicotine-free tobacco. Without any artificial extraction or chemical
processes, 22nd Century’s BRAND A cigarettes are made with the Company’s
proprietary VLN tobacco that is grown on independently-owned farms in
the United States. The finished cigarettes have the taste and sensory
characteristics of conventional cigarettes, but contain only trace
amounts of nicotine so that smokers’ exposure to nicotine is drastically
reduced.

Under Section 911 of the federal Food, Drug, and Cosmetic Act, a tobacco
product may not be introduced for commerce in the United States if the
label or advertising represents that the tobacco product contains a
reduced level of a substance or a reduced exposure to a substance unless
given specific approval to do so by the FDA.

“The scientific testing conducted in support of our submission to the
FDA shows conclusively that BRAND A, as compared to conventional tobacco
cigarettes, provides smokers with drastically reduced exposure to
nicotine,” explained Henry Sicignano, III, President and Chief Executive
Officer of 22nd Century Group. “We believe that the public health
implications of a virtually nicotine-free tobacco cigarette are enormous
and 22nd Century is excited about the prospect of introducing BRAND A
into the U.S. market.”

It has been well established that cigarette smoking is toxic and poses
health risks to smokers. Cigarette smoking is a complex behavior that is
sustained primarily by the pharmacological properties of nicotine.
Accordingly, many public health officials believe it is a critically
important health need to provide consumers with a product that reduces
exposure to nicotine. This fact echoes former U.S. FDA Commissioner Dr.
David Kessler’s recommendation that “the FDA should quickly move to
reduce nicotine levels in cigarettes to non-addictive levels… It is the
ultimate harm reduction strategy.”

Unlike so-called “light” or “ultra-light” cigarettes (which terms are
now banned by the FDA from labeling and marketing in the United States),
22nd Century’s proprietary BRAND A cigarettes are designed to deliver
greatly reduced ratios of nicotine to other smoke components. The
Company’s application to the FDA provides a comprehensive overview of
the many independent clinical trials that have found that smoking 22nd
Century’s VLN cigarettes delivers the sensory and behavioral experience
associated with conventional cigarettes while providing only minimal
exposure to the most addictive component of tobacco.

Most recently, in October 2015, The New England Journal of Medicine
published a landmark clinical study N
Engl J Med 2015; 373:1340-1349 led by the Center for the
Evaluation of Nicotine in Cigarettes. The double-blind, parallel,
randomized clinical trial by Donny et al involved 840 smokers at
ten locations who were randomly assigned to smoke for 6 weeks either
their usual brand of cigarettes or one of six types of investigational
cigarettes. The researchers concluded that:

“The current study by Donny and colleagues adds to a growing literature
supporting the feasibility and potential benefits of a national nicotine
reduction policy…” explained public health policy reform advocates, Drs.
Michael Fiore and Timothy Baker in a companion article (Fiore)
in the same issue of The New England Journal of Medicine.
“Reducing the nicotine content of combustible tobacco to levels that
will not sustain dependence seems to us to be the most promising
regulatory policy option for preventing [at least] 20 million premature
deaths.”

The available scientific literature shows that smoking 22nd Century’s
VLN cigarettes results in reduced nicotine exposure with minimal
compensatory smoking behavior and no greater exposure to harmful or
potentially harmful toxicants, particularly when exposure is maintained
for longer than one week. Similarly the prolonged use of VLN cigarettes
seems to result in a decrease in dependence.

“It is the goal of the U.S. Department of Health and Human Services, as
outlined in the program Healthy People 2010, to reduce cigarette smoking
in the United States to 12% by the year 2020,” explained Gregg M.
Gellman, 22nd Century’s Director of Regulatory Affairs. “Based on the
scientific rationale and clinical data referenced in our application to
the FDA, we believe 22nd Century’s proprietary Very Low Nicotine
cigarettes could be an invaluable tool in helping to drastically reduce
smokers’ exposure to nicotine and thereby greatly reducing cravings for,
and consumption of, cigarettes.”

With approximately 277 billion cigarettes manufactured in the U.S. in
2014 – representing more than $80 billion in sales – the cigarette
market in the United States remains enormous. At present, however, the
United States is completely devoid of any “reduced exposure cigarette”
option. If 22nd Century’s application to the FDA is successful, the
Company’s VLN cigarettes will offer millions of American smokers a
distinct reduced exposure product choice.

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on technology
which allows it to increase or decrease the level of nicotine in tobacco
plants and the level of cannabinoids in cannabis plants through genetic
engineering and plant breeding. The Company’s primary mission is to
reduce the harm caused by smoking. 22nd Century currently owns or
exclusively controls more than 200 issued patents and more than 50
pending patent applications around the world. The Company’s strong IP
position led to a licensing agreement with British American Tobacco
(“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com
for more information.

Cautionary Note Regarding Forward-Looking Statements:This
press release contains forward-looking information, including all
statements that are not statements of historical fact regarding the
intent, belief or current expectations of 22nd Century Group, Inc., its
directors or its officers with respect to the contents of this press
release, including but not limited to our future revenue expectations.
The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,”
“believe,” “intend” and similar expressions and variations thereof are
intended to identify forward-looking statements. We cannot guarantee
future results, levels of activity or performance. You should not place
undue reliance on these forward-looking statements, which speak only as
of the date that they were made. These cautionary statements should be
considered with any written or oral forward-looking statements that we
may issue in the future. Except as required by applicable law, including
the securities laws of the United States, we do not intend to update any
of the forward-looking statements to conform these statements to reflect
actual results, later events or circumstances, or to reflect the
occurrence of unanticipated events. You should carefully review and
consider the various disclosures made by us in our annual report on Form
10-K for the fiscal year ended December 31, 2014, filed on February 5,
2015, including the section entitled “Risk Factors,” and our other
reports filed with the U.S. Securities and Exchange Commission which
attempt to advise interested parties of the risks and factors that may
affect our business, financial condition, results of operation and cash
flows. If one or more of these risks or uncertainties materialize, or if
the underlying assumptions prove incorrect, our actual results may vary
materially from those expected or projected.